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Withdrew IRB application, never approved and no subjects enrolled
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Open label single center study for the donation of HCV positive kidneys to HCV negative recipients with interventional treatment to prevent HCV transmission upon transplantation.
The study objective is to determine if the administration of direct acting antivirals for 12-16 weeks after kidney transplantation prevents the spread of HCV infection from donor kidney with known HCV infection (all genotypes) to an HCV negative recipient as evidenced by a negative HCV viral RNA at 12 weeks post treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCV treatment - no viral resistance | Experimental | Based on the genotype and negative viral resistance testing of the donor, (determined within the first week) we will initiate a genotype specific regimen of Zepatier |
|
| HCV treatment - viral resistance | Experimental | Based on the genotype and positive viral resistance testing of the donor, (determined within the first week) we will initiate a genotype specific regimen of Zepatier plus Sofosbuvir |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zepatier | Drug | Based on negative viral resistance testing of the donor treatment will be Zepatier |
|
| Measure | Description | Time Frame |
|---|---|---|
| Undetectable HCV RNA | Negative HCV viral load 12 weeks after last dose of treatment | 12 weeks post treatment |
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Inclusion Criteria:
Donor meets MGH transplant center criteria and already listed for isolated kidney transplant
No available living kidney donor
Recipient has ≤ 730 days of accrued transplant waiting time
Recipient chronic hemodialysis or peritoneal dialysis
Recipient must agree to birth control.
°.Weigh ≥ 50kg
Serum ALT within normal limits
Subject's Insurance company approves payment for DAA therapy post-kidney transplant
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raymond Chung, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
No current plans to share participant data
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006526 | Hepatitis C |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000611265 | elbasvir-grazoprevir drug combination |
| D000069474 | Sofosbuvir |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
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Based on the genotype and viral resistance testing of the donor, that will be determined within the first week, we will initiate a genotype specific regimen for HCV treatment as available by prescription
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| Zepatier plus Sofosbuvir | Drug | Based on positive viral resistance testing of the donor treatment will be Zepatier with Sofosbuvir |
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |